Manufacturer ref# (b)(4).Catalog # igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.Sheath found kinked where filter was attached to grasping hook.Marks on tip of protection sheath - probably caused by barbs of primary legs.However, by reloading the filter in the protection sheath, the primary legs collapsed nicely to obtain a correct reloading from femoral to jugular introducer.Filter could be reloaded several times without any kind of resistance, why exact reason for difficulties encountered when attempting to "pass the filter through the diaphram" cannot be determined.There is found no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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